NCT04257487

Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)

Sulodexide (VESSEL®) for the Prevention of Recurrent Venous Thromboembolism in Elderly Patients After a First Episode of Venous Thrombembolism

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,455 (estimated)
• Sponsor: Arianna Anticoagulazione Foundation · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The study aims at optimizing extended management of elderly patients (\> 75 years) with at least one of the known bleeding risk factor, who suffered from first episode of venous thromboembolism of the lower extremity (proximal deep vein thrombosis with or without pulmonary embolism) (VTE). Patients were randomized to receive three different treatment: Sulodexide 250 mg BIS in die; Sulodexide 500 BID in die or indistinguishable placebo to verify the efficacy and safety of extended treatment for 12 months with Sulodexide (Vessel®) in the secondary prevention of Deep Vein Thrombosis / Pulmonary Embolism (DVT/PE) recurrence.

Detailed description

This prospective cohort study aims to assess the efficacy and safety of the extended treatment with Sulodexide (Vessel®) in the secondary prevention of DVT / PE recurrence in elderly outpatients (≥ 75 years old at the time of inclusion) ), with at least one of the known bleeding risk factor, who had a first episode of lower extremity proximal DVT and / or PE, idiopathic or associated with weak or removed risk factors, and who have received standard treatment with any oral anticoagulant drug lasting at least 3 months. The study seeks to verify the safety of the Sulodexide therapy, demonstrating non-inferiority compared to placebo, with an incidence of major bleeding around 1% (upper confidence limit not \> 3%).

Conditions

• Venous Thromboembolism
• Anticoagulant
• Elderly

Interventions

Type	Name	Description
DRUG	Sulodexide	2 soft capsules of Vessel® 250 LSU BID for 12 months
DRUG	Sulodexide and placebo	1 soft capsule of Vessel® 250 LSU and 1 soft capsule of placebo BID for 12 months
DRUG	Placebo	Sugar pill manufactured to mimic sulodexide 250 LSU

Timeline

• Start date: 2020-12-21
• Primary completion: 2025-12-31
• Completion: 2027-01-02
• First posted: 2020-02-06
• Last updated: 2024-07-31

Locations

1 site across 1 country: Italy